BMJ Open · 17 authors, 7 centres
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This protocol describes a randomized trial comparing intense pulsed light (IPL) alone, 3% diquafosol (DQS) alone, and their combination in 360 patients with evaporative dry eye. The primary outcomes are non-invasive tear break-up time and Ocular Surface Disease Index change from baseline over 4 weeks. The study aims to determine if combination therapy is more effective than either monotherapy.
**Background:** Evaporative dry eye (EDE) is the most prevalent form of dry eye disease, primarily caused by meibomian gland dysfunction (MGD). Intense pulsed light (IPL) therapy has been shown to improve meibomian gland function through its photothermal effect, while 3% diquafosol (DQS) ophthalmic solution stimulates mucin and tear secretion by binding to P2Y2 receptors. Although both treatments have demonstrated efficacy individually, no randomized controlled trial has evaluated their combined use. This protocol describes a study designed to assess whether the combination of IPL with DQS is more effective than either treatment alone in alleviating signs and symptoms of dry eye disease.
**Methods:** This is a prospective, randomized, triple-masked, parallel-group trial conducted at He Eye Specialist Hospital (HESH) in Shenyang, China, from March 2023 to November 2023. A total of 360 patients with dry eye disease will be enrolled and randomly assigned in a 1:1:1 ratio to three groups: IPL group (two IPL sessions 2 weeks apart), DQS group (3% diquafosol ophthalmic solution six times/day for 4 weeks), and IPL+ group (IPL combined with DQS using the same regimens). Inclusion criteria are age ≥18 years, Ocular Surface Disease Index (OSDI) ≥13, non-invasive tear break-up time (NITBUT) ≤5 seconds, and conjunctival staining score ≥3. Exclusion criteria include recent topical ophthalmic medication use, active ocular infection or allergy, glaucoma, diabetes, systemic diseases affecting the ocular surface, and contact lens wear. The primary outcomes are change from baseline in NITBUT and OSDI at 4 weeks. Secondary outcomes include fluorescein and lissamine conjunctival/corneal staining, tear meniscus height, conjunctival hyperemia (redness score), meibomian gland function and secretion quality, and tear film lipid layer score. Adverse events will be monitored throughout. Sample size calculation: 106 patients per group are needed to detect a clinically significant difference of 0.51 in NITBUT (SD 1.15) and 1.2 in OSDI (SD 2.6) with 90% power and 5% significance. Accounting for 8% dropout, 120 patients per group (360 total) will be enrolled. Statistical analysis will use two-way ANOVA, paired t-tests, and analysis of covariance with baseline as covariate.
**Key Results:** This is a protocol paper; no results are reported. The study is currently in the recruitment phase (March–November 2023). The primary analysis will compare the IPL+ group versus IPL alone and DQS alone for changes in NITBUT and OSDI at 4 weeks. Secondary outcomes will be analyzed similarly. Safety data will be summarized descriptively.
**Clinical Implications:** If the combination of IPL and DQS proves superior to either monotherapy, it could provide a more effective treatment option for patients with evaporative dry eye, potentially improving both tear film stability and ocular surface health. The study's triple-masked design and rigorous outcome measures will provide high-quality evidence to guide clinical practice. The results will be disseminated regardless of direction of effect, contributing to the evidence base for dry eye management.